Mar 12 2009
Oncolytics Biotech Inc. has announced that it has started patient enrolment in a Phase 2 clinical trial using intravenous administration of Reolysin in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumours.
The Principal Investigator is Dr. Miguel Villalona-Calero, Professor, Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center. "We are quite excited about this trial, since there are no known therapies that to date have effectively targeted K-RAS in cancer patients," said Dr. Villalona-Calero. "If this therapy works, this could substantially impact the outlook for our patients."
This trial (REO 016) is a single arm, single-stage, open-label, Phase 2 study of Reolysin given intravenously with paclitaxel and carboplatin every 3 weeks. Patients will receive four to six cycles of paclitaxel and carboplatin in conjunction with Reolysin, at which time Reolysin may be continued as a monotherapy. It is anticipated that up to 36 patients will be treated in this trial.
Eligible patients include those with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, who have not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in K-RAS or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.
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